Remote Monitoring of Chronic Heart Failure in Veneto Region
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Purpose
The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.
| Condition | Intervention |
|---|---|
|
Congestive Heart Failure |
Other: Usual care Procedure: Telemonitoring for patients with Congestive Heart Failure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure |
- Combined end point of all cause mortality and number of hospitalisations for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Cardiovascular and all-cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Health-Related Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]Health-Related Quality of Life is assessed by the SF-36 questionnaire
- Number of hospitalisations (including rehospitalisations) for all causes and for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Total number of days in hospital [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of specialist visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of visits at emergency department for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Anxiety and depression status [ Time Frame: 12 months ] [ Designated as safety issue: No ]Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)
| Estimated Enrollment: | 315 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control group
Treatment as usual
|
Other: Usual care
Participants in the control group receive usual care that depends on the organisation of each local health authority. Patients with CHF have regular outpatient visits to the specialist and primary care clinics with a frequency depending on the their health conditions |
| Experimental: Telemonitoring for patients with Congestive Heart Failure |
Procedure: Telemonitoring for patients with Congestive Heart Failure
Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission. The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the reference clinician in case of worsening of symptoms. |
Detailed Description:
The study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professional perception towards the service.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 65 years.
- Discharge from hospital after acute heart failure in the previous 3 months and EF < 40% or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization
Exclusion Criteria:
- Comorbidities prevalent on CHF with life expectation < 12 months.
- Impossibility or inability to use the equipment and help at home not available.
- Myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled.
- Coronary artery bypass, valve substitution or correction in the last 6 months.
- Being on waiting list for heart transplantation.
- Being enrolled in other trial
Contacts and Locations| Contact: Zoran Olivari, MD | 0422322767 | segcardiotv@ulss.tv.it |
| Contact: Gianluigi Scannapieco, MD | 0422323232 | gscannapieco@ulss.tv.it |
| Italy | |
| Ospedale Immacolata Concezione - Cardiology Department | Recruiting |
| Piove di Sacco, Padova, Italy, 35028 | |
| Principal Investigator: Domenico Marchese, MD | |
| Presidio ospedaliero di Conegliano - Department of Cardiology | Recruiting |
| Conegliano, Treviso, Italy, 31015 | |
| Principal Investigator: Carlo Marcon, MD | |
| Ospedale di Mirano - Cardiology Department | Recruiting |
| Mirano, Venezia, Italy, 30035 | |
| Principal Investigator: Emanuele Bertaglia, MD | |
| Ospedale San Fracastoro - Cardiology Department | Recruiting |
| San Bonifacio, Verona, Italy, 37047 | |
| Principal Investigator: Maurizio Anselmi, MD | |
| Principal Investigator: Claudio Bellamoli, MD | |
| Azienda Ospedaliera di Padova - Cardiology Department | Recruiting |
| Padova, Italy, 35128 | |
| Principal Investigator: Sabino Iliceto, MD | |
| Ospedale Ca'Foncello - Pulmonology Department | Recruiting |
| Treviso, Italy, 31100 | |
| Principal Investigator: Zoran Olivari, MD | |
| Ospedale SS Giovanni e Paolo - Cardiology Department | Recruiting |
| Venezia, Italy, 30122 | |
| Principal Investigator: Michelangelo Penzo, MD | |
| Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department | Recruiting |
| Verona, Italy, 37124 | |
| Principal Investigator: Vincenzo Di Francesco, MD | |
| Principal Investigator: | Zoran Olivari, DM | Unità Locale Socio Sanitaria di Treviso |
More Information
Additional Information:
Publications:
| Responsible Party: | Regione Veneto |
| ClinicalTrials.gov Identifier: | NCT01513993 History of Changes |
| Other Study ID Numbers: | G. A. 250487-Veneto WP8Cl7 |
| Study First Received: | January 17, 2012 |
| Last Updated: | January 20, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Regione Veneto:
|
CHF Telemonitoring |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013